The following data is part of a premarket notification filed by Simmler, Inc. with the FDA for Multichem Alkaline Phosphatase (s0903).
Device ID | K873761 |
510k Number | K873761 |
Device Name: | MULTICHEM ALKALINE PHOSPHATASE (S0903) |
Classification | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes |
Applicant | SIMMLER, INC. POST OFFICE BOX 25179 St. Louis, MO 63125 |
Contact | Quincy E Crider,phd |
Correspondent | Quincy E Crider,phd SIMMLER, INC. POST OFFICE BOX 25179 St. Louis, MO 63125 |
Product Code | CJE |
CFR Regulation Number | 862.1050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-09-16 |
Decision Date | 1987-10-07 |